Early antenatal exposure to low-dose aspirin neither worsened nor improved kids’ neurodevelopment, according to a follow-up study to the multinational ASPIRIN trial.
Bayley Scales of Infant and Toddler Development (Bayley-III) cognitive composite scores indicated no difference with low-dose aspirin compared to placebo. The adjusted mean difference of -0.8 points (95% CI -2.2 to 0.60) fell well within the 4-point margin for noninferiority on a scale with a standard deviation of 15.
Additionally, communication, gross and fine motor control, problem solving, and personal-social measures on the Ages & Stages Questionnaire, 3rd Edition (ASQ-3), didn’t differ between groups, reported Matthew Hoffman, MD, MPH, of Christiana Care in Newark, Delaware, and colleagues writing in Obstetrics & Gynecology.
While Hoffman told MedPage Today that the team expected these findings, “we felt that this information would be important for parents and providers to feel comfortable in providing aspirin during pregnancy.”
“We can now say with a great deal of surety that we do not see any negative impact on children who were exposed as early as 6-week fetuses,” he said.
Authors also found that maternal characteristics, delivery outcomes, breastfeeding, and family care indicators were similar between the aspirin and placebo groups, as were the language composite scores (101.2 vs 100.4, P=0.38) and motor composite scores (99.4 vs 100.1, P=0.50).
Main findings from the ASPIRIN randomized controlled trial showed that women randomized to low-dose aspirin during pregnancy, beginning as early as 6 weeks’ gestation, had lower rates of preterm birth, preterm hypertensive disorders, and perinatal mortality. Hoffman said that current guidelines result in about half of pregnant people being offered aspirin, although fewer actually take it “in part because of parents’ concerns about the long-term impact on neurodevelopment.”
Ultimately, the authors concluded the study’s findings “demonstrate that low-dose aspirin is not associated with changes in neurodevelopment or postnatal growth within the parameters and age groups in which it was tested.”
“We were able to look at development using a number of different instruments and different domains and saw no differences in children who were exposed to aspirin early in pregnancy and those who were not,” Hoffman said. He added, however, that future research should look at higher doses of aspirin to see if it lowers rates of preeclampsia and preterm birth or improves neurodevelopment, since it’s already known that inflammation negatively impacts development.
Cynthia Gyamfi-Bannerman, MD, MS, department chair of obstetrics, gynecology, and reproductive sciences at UC San Diego Health, told MedPage Today this study bolsters the safety profile for aspirin in pregnancy.
“While there was not thought to be concern for aspirin use during pregnancy, we did not have ample data when aspirin was started at less than 12 weeks of gestation, as current guidelines suggest starting the medication at 12 weeks,” Gyamfi-Bannerman said. Even with the evidence, though, she predicted many clinicians would wait for guideline updates from professional societies before changing their practice.
The ASPIRIN trial randomly assigned pregnant women to a daily 81-mg dose of aspirin or placebo. Participants resided in India, the Democratic Republic of Congo, Guatemala, Pakistan, and Zambia. Kids born with major congenital anomalies or medical conditions that would make it hard to assess neurodevelopment were excluded.
In total, 640 children were eligible, with 329 in the low-dose aspirin group (mean maternal age 21) and 311 in the placebo group (mean maternal age 20). Between age 33 and 39 months, the neurodevelopment of those children was assessed with the Bayley-III and ASQ-3 tools, led by a credentialed examiner and administered orally by trained assessors.
The authors cited the limitations of the parent study as well as being unable to detect meaningful differences of less than 4 points on the Bayley-III examination. Only 61 babies were born preterm, which limited their ability to test the hypothesis in this group. Gyamfi-Bannerman also pointed out that because the sample size was a small subset of the original trial — less than 700 of the 11,976 ASPIRIN trial participants — there was some potential for a biased sample.
The study was funded by the Thrasher Research Fund.
Hoffman had no conflicts of interest.
Other co-authors reported financial ties to Nurture, The Danone Company, Pediatric and Maternal Nutrition, Happy Family Advisory Board, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Fogarty International Center, the Foundation for the National Institutes of Health, the Bill and Melinda Gates Foundation, and the Thrasher Foundation.
Gyamfi-Bannerman had no conflicts of interest.
Obstetrics & Gynecology
Source Reference: Hoffman M, et al “Neurodevelopment of children whose mothers were randomized to low-dose aspirin during pregnancy” Obstet Gynecol 2024; DOI:10.1097/AOG.0000000000005514.
Source link : https://www.medpagetoday.com/obgyn/pregnancy/108476
Publish date : 2024-01-29 15:32:53
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